(53 days)
MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.
The MLI Soft Tissue Screw and Washer System is an assembly unit consisting of MLI Soft Tissue Anchoring Screws and MLI Washers. The screws are provided in standard sizes (4.5 mm Cortical and 6.5 mm Cancellous) and conform to ISO 5835. They are self-tapping and inserted manually with a 3.5 mm hex driver. The washers are universally compatible with both screw sizes and come in three design configurations (Round, Triangular, Oval) with spikes on the distal side to penetrate bone and anchor the graft.
This is a premarket notification for a medical device (MLI Soft Tissue Screw and Washer System), not an AI/ML-powered device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the MLI Soft Tissue Screw and Washer System to predicate devices through mechanical testing. Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical "acceptance criteria" for the MLI device. Instead, it aims to demonstrate substantial equivalence by showing that the MLI screw/washer constructs performed "as well or better than" the predicate screw/washer construct in yield load tests.
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fixation strength (Yield Load) of various MLI screw/washer configurations in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model (Tests #1, #2, #3, #4) | Performance (yield load) must be "as well or better than" the currently marketed predicate screw/washer construct. | "When the yield load results for the various MLI Soft Tissue Screw and Washer System screw/washer constructs were compared to the currently marketed screw/washer construct, the MLI screw/washer constructs all performed as well or better than the predicate screw/washer construct." |
| Mode of failure for all MLI Screw and Washer configurations | Mode of failure should be similar to published results for ligament anchorage to an implant (i.e., ligament pulling out from under the washer). | "The mode of failure for all MLI Screw and Washer configurations was similar for all screw/washer constructs tested, wherein the ligament pulled out from under the washer. The modes of failure are also consistent with results obtained by Matthews et.al and Kurosaka et.al where the site of failure was at the point of ligament anchorage to the implant." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "a variety of screw/washer configurations" (four specific tests are listed) and compares them to "the currently marketed screw/washer construct." It does not specify the number of individual tests or samples conducted for each configuration.
- Data provenance: The testing was conducted by MedicineLodge, Inc. (manufacturer). The data is from prospective in-house mechanical testing. The "country of origin" is not specified but is implied to be within the US, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, in the context of this document, refers to the physical measurement of mechanical properties (yield load and mode of failure) from the testing. These are objective measurements, not subjective evaluations requiring expert consensus for ground truth establishment.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods are typically used for subjective assessments where there might be disagreement among reviewers, which is not the case for mechanical testing results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This is a non-AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable. This is a non-AI/ML device.
7. The type of ground truth used:
The ground truth used was mechanical testing results and observed modes of failure.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an AI/ML device. The testing was conducted to demonstrate the performance and substantial equivalence of the physical device.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set." The ground truth for the performance evaluation was established through controlled mechanical testing as described in the "DEVICE TESTING" section.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.